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This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse.

Back to Coronary Intervention
MAUDE LookupCoronary InterventionXIENCE XPEDITION

XIENCE XPEDITION Adverse Events: FDA MAUDE Data

ABBOTT VASCULAR INC. · Coronary Drug-Eluting Stent · First cleared Sep 2016

Total Reports

2,158

Reports (30d)

12

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Distal Edge Dissection After Implantation

significant delay, dissection adverse, xpedition, treat, dissection

30

reports

2

Edge Dissection Treated with New Stent

sierra stent, treat, dissection, delay, xience sierra

2

reports

3

In-Hospital Stent Thrombosis After Implant

thrombosis, article, patients, myocardial infarction, death

2

reports

4

Stent Detachment During Preparation Process

sds, delay procedure, clinically, significant delay, delay

2

reports

5

Dislodged Stent from Delivery System

procedure treat, skypoint stent, skypoint, sds, xience skypoint

1

reports

6

Patient Death Following Stent Placement

synergy, cardiac, reference, lesion located, died

1

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Detection

Active safety signals

Disproportionate reportinghigh

Evidence

Related research

Procedural and One-Year Clinical Outcomes of Long 48 mm Xience Xpedition Everolimus-Eluting Stent in Complex Long Diffuse Coronary Artery Lesions.

Hsiao FC, et al. · 2022

Treatment with 48-mm everolimus-eluting stents : Procedural safety and 12-month patient outcome.

Tan CK, et al. · 2018

Safety and efficacy of 48 mm Xience Xpedition everolimus-eluting stent for the treatment of long coronary lesions.

Gautier A, et al. · 2022

Zotarolimus-eluting Resolute Integrity versus everolimus-eluting Xience Xpedition stents in the management of very long (>30mm) de novo coronary artery stenosis.

Patra S, et al. · 2016

Procedural Safety and Long-Term Clinical Outcomes in Patients Receiving Ultra-Long Everolimus-Eluting Stent: A Single-Center Real-World Experience.

Senguttuvan NB, et al. · 2022

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.